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NCT04792216 · ClinicalTrials.gov registry record · NA
Salmon Intake and Gut Health in Adults
A NA study of Inflammation and Gut Microbiome, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04792216: Completed NA study of Inflammation and Gut Microbiome, sponsored by University of Colorado, Denver.
NCT04792216 is a NA study of Inflammation and Gut Microbiome that has completed, run by University of Colorado, Denver. The registered enrollment target is 40 participants, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04792216, a NA study of Inflammation and Gut Microbiome, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall objective of this project is to determine the interplay of salmon as a whole food and its bioactive compound astaxanthin on gut microbiome, fecal metabolome, and inflammation in obese prediabetic individuals. Our central hypothesis is that dietary bioactive astaxanthin in the form of whole food salmon will effectively reduce inflammation in obese prediabetic individuals, and favorably change the gut microbiota composition and diversity. The investigators anticipate that these changes will result in improved metabolic outcomes in obesity and type 2 diabetes. The two primary aims include: Aim 1: Assess the anti-inflammatory effect of the salmon dietary intervention and the underlying mechanisms on the change in plasma levels of inflammatory cytokines important for the host immune response. Aim 2: Identify whether the relationship between salmon consumption and decreased inflammation is mediated by the gut microbiome.
Primary Outcome
Blood from patients will be processed via centrifugation to archive plasma. A panel of 48 factors from Bio-Rad (Bio-Plex Pro™ Human Cytokine Screening Panel, 48-Plex #12007283) will be measured in plasma by Bio-Rad Bio-Plex analyzer. Five primary biomarkers (IL-1β, IL-6, IL-10, TNF-α, and MCP-1) will be confirmed by traditional ELISA
Conditions Studied
Interventions
- OTHER Wild Salmon
- OTHER Farmed Salmon
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2023-04-30 |
| Phase | NA |
What the finished NCT04792216 record still lists
NCT04792216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Inflammation appearing as the primary indexed condition, and to 2 interventions - of which Wild Salmon is the first listed.
NCT04792216 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04792216 about?
NCT04792216 is a clinical study titled "Salmon Intake and Gut Health in Adults". The overall objective of this project is to determine the interplay of salmon as a whole food and its bioactive compound astaxanthin on gut microbiome, fecal metabolome, and inflammation in obese prediabetic individuals. Our central hypothesis is that dietary bioactive astaxanthin in the form of who...
What is the current status of trial NCT04792216?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2021-08-01. Estimated completion is 2023-04-30.
What conditions does trial NCT04792216 study?
This clinical trial studies the following conditions: Inflammation, Gut Microbiome.
What interventions are being tested in trial NCT04792216?
The interventions under investigation include: Wild Salmon (OTHER), Farmed Salmon (OTHER).
Who is sponsoring clinical trial NCT04792216?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04792216 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04792216's enrollment target sits among peer trials
40 83rd of 132 higher than 46 of 132 other Inflammation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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